Approaches to Patient Safety of Digital Health Interventions for Diabetes Management: A Mixed-Methods Systematic Review

Abstract

BACKGROUND—Digital health interventions (DHIs) have become prominent tools in diabetes management. The emerging safety-related concerns associated with diabetes DHIs are unclear. The regulatory challenges to standardise and monitor DHIs presents a dearth of evidence around the safety of DHIs for diabetes management. AIM—To identify and appraise the current evidence on approaches to patient safety in DHIs designed to support remote diabetes management. METHODS—A mixed-method systematic review, guided by the HITS conceptual framework for patient safety, was conducted. MEDLINE and Web-of-Science were systematically searched. The retrieved quantitative and qualitative studies (published:2010-2020) were tested against pre-defined eligibility criteria. RESULTS—44 studies were included in the integrated syntheses, and categorised into: telehealth platforms, self-management applications, and active monitoring and automatic calculators. Of which, half(23/44) were deemed to be higher-risk, as described by the NICE evidence standards. The conceptualisation of the HITS dimensions revealed several explanatory patterns: clinical safety was the commonly discussed aspect; concerns linked to technologies and data security were less likely to be reported, particularly, among lower-risk diabetes DHIs; discussion of safety issues appeared to be irrespective to high-quality research. CONCLUSIONS—The HITS framework can offer insights to analyse clinical and technical safety concerns associated with diabetes DHIs. Current evidence-drought around patient safety in diabetes DHIs could be enriched by improving the evolving evidence standards to rigorously address how technologies work in the real context. This review contributes to work aiming to standardise evidence required to evaluate the safety and efficacy of the existing unregulated DHIs.